Reported Feb 28, 2018 · Terminated
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in…
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LLC · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- GastriSail" Gastric
- Positioning Device Product UsageThe GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy
- Lot codes and dates
- Product numbersGPS36 (Pediatric)
- GPS40 (Adult) Lot codes
129 of 129 codes
E6J0001XE6J0002XE6J0003XE6J0004XE6J0005XE6J0006XE6J0007XE6J0008XE6J0009XE6J0010XE6J0011XE6J0012XE6J0013XE6J0014XE6J0015XE6J0016XE6J0017XE6J0018XE6J0019XE6J0020XE6K0001XE6K0002XE6K0003XE6K0004XE6K0005XE6K0006XE6K0007XE6K0008XE6K0009XE6K0010XE6K0011XE6K0012XE6K0013XE6K0014XE6K0015XE6K0016XE6K0017XE6K0018XE6K0019XE6K0020XE6K0021XE6K0022XE6K0023XE6K0024XE6K0025XE6L0001XE6L0002XE6L0003XE6L0004XE6L0005XE6L0006XE6L0007XE6L0008XE6L0009XE6L0010XE6L0011XE6L0012XE6L0013XE6L0014XE6L0015X
- Amount recalled
- 17,271 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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